DANBURY, CT, USA I December 04, 2014 I Biodel Inc. (BIOD) today announced that the company has initiated enrollment of normal human subjects in a Phase 1 clinical trial of its lyophilized glucagon formulation designed for use in a proprietary auto-reconstitution device intended for the rescue of patients with severe hypoglycemia. The combination of the formulation and the auto-reconstitution device constitutes the Glucagon Emergency Management (GEM) system, which is intended to be a more user-friendly glucagon presentation compared to emergency kits currently marketed by Eli Lilly and Novo Nordisk. The Phase 1 proof of concept study is a 6-arm cross over trial in 12 healthy volunteers in which the pharmacokinetics, pharmacodynamics, and safety of 1 mg doses of the GEM glucagon formulation, administered subcutaneously and intramuscularly, will be compared to similar injections of both marketed glucagon products.
“These data will be help finalize the design and select the comparator to be used in the pivotal bioequivalence study,” said Alan Krasner, MD, Chief Medical Officer of Biodel. Dr. Errol De Souza, president and chief executive officer of Biodel, stated: “We continue to advance the GEM program with the initiation of clinical development while our partner Unilife manufactures the molds necessary for production and delivery to Biodel of registration lots. We look forward to reporting the top line results of the Phase 1 proof of concept GEM study in late first quarter of 2015.”
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. Biodel’s product candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information about Biodel is available at www.biodel.com.
SOURCE: Biodel
Post Views: 56
DANBURY, CT, USA I December 04, 2014 I Biodel Inc. (BIOD) today announced that the company has initiated enrollment of normal human subjects in a Phase 1 clinical trial of its lyophilized glucagon formulation designed for use in a proprietary auto-reconstitution device intended for the rescue of patients with severe hypoglycemia. The combination of the formulation and the auto-reconstitution device constitutes the Glucagon Emergency Management (GEM) system, which is intended to be a more user-friendly glucagon presentation compared to emergency kits currently marketed by Eli Lilly and Novo Nordisk. The Phase 1 proof of concept study is a 6-arm cross over trial in 12 healthy volunteers in which the pharmacokinetics, pharmacodynamics, and safety of 1 mg doses of the GEM glucagon formulation, administered subcutaneously and intramuscularly, will be compared to similar injections of both marketed glucagon products.
“These data will be help finalize the design and select the comparator to be used in the pivotal bioequivalence study,” said Alan Krasner, MD, Chief Medical Officer of Biodel. Dr. Errol De Souza, president and chief executive officer of Biodel, stated: “We continue to advance the GEM program with the initiation of clinical development while our partner Unilife manufactures the molds necessary for production and delivery to Biodel of registration lots. We look forward to reporting the top line results of the Phase 1 proof of concept GEM study in late first quarter of 2015.”
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. Biodel’s product candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information about Biodel is available at www.biodel.com.
SOURCE: Biodel
Post Views: 56
